Cleared Abbreviated

K080598 - MINI DRIVE-LOCK DENTAL IMPLANT SYSTEM PROSTHETICS

K080598 is an FDA 510(k) clearance for MINI DRIVE-LOCK DENTAL IMPLANT SYSTEM P..., manufactured by Intra-Lock International. The device is a Class 2 Dental device with product code NHA cleared through the Abbreviated 510(k) pathway after a 79-day FDA review.

K080598 · Intra-Lock International · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2008
Decision
79d
Days
Class 2
Risk

K080598 is an FDA 510(k) clearance for the MINI DRIVE-LOCK DENTAL IMPLANT SYSTEM PROSTHETICS. Classified as Abutment, Implant, Dental, Endosseous within the NHA classification (a category for dental implant abutments and prosthetic components), Class II - Special Controls.

Submitted by Intra-Lock International (Boca Raton, US). The FDA issued a Cleared decision on May 21, 2008 after a review of 79 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3630 - the FDA dental device regulatory framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K080598

510(k) Number K080598 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 2008
Decision Date May 21, 2008
Days to Decision 79 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 128d · This submission: 79d
Pathway characteristics
Standards-based clearance path.

NHA Device Classification - Class 2, Special Controls

Product Code NHA Abutment, Implant, Dental, Endosseous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3630
Definition To Be Used In Conjunction With An Endosseous Dental Implant Fixture To Aid In Prosthetic Rehabilitation.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - NHA Abutment, Implant, Dental, Endosseous

All 715
Devices cleared under the same product code (NHA) and FDA review panel - the closest regulatory comparables to K080598.
ACCUFRAME
K081157 · Cagenix, Inc. · Jul 2008
CAM STRUCTSURE PRECISION MILLED BARS
K080864 · Biomet 3i, Inc. · Jul 2008
CONCAVE RN HEALING CAP
K081186 · Institut Straumann AG · May 2008
INCLUSIVE IMPLANT ABUTMENTS
K073217 · Inclusive Dental Solutions · May 2008
AMERICAN DENTAL IMPLANT ABUTMENT SYSTEM
K080397 · American Dental Implant Corporation · May 2008
P.004 NC CARES TITANIUM AND CERAMIC ABUTMENTS
K081005 · Institut Straumann AG · May 2008
K080598 · MINI DRIVE-LOCK DENTAL IMPLANT SYSTEM PROSTHETICS
Download PDF FDA Summary Intra-Lock Internatio…